Real-world data vital to assessing device safety, effectiveness

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Data collected from electronic health records, registries and wearable technology can be valuable sources of “real-world” data and evidence—just as valid as clinical trials—in helping the Food and Drug Administration to make regulatory decisions about the safety and effectiveness of medical devices.

That’s the contention of Health IT Now, a coalition of providers, patient advocates, consumers and payers, which provided written comments to the FDA regarding its draft guidance entitled Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.

“HITN appreciates the Food and Drug Administration’s focus on real-world evidence (RWE) and real-world data (RWD) to support new device or new indication applications,” wrote HITN Executive Director Robert Horne in an October 25 letter to FDA Commissioner Robert Califf, MD. “RWE and RWD will accelerate the device-to-market speed without compromising patient safety; however, we believe there are some areas where the guidance can be improved before finalizing.”

While the FDA’s guidance “begins to build needed clarity and assurance in this process, and will be essential to the success of recent administration efforts such as the Precision Medicine Initiative or the Cancer Moonshot,” Horne argued that what is lacking is a “clear and consistent process and means to use data collected from sources” such as EHRs, disease registries, and wearables in support of research and development.

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Horne makes several recommendations to the regulatory agency, including:

  • The agency can/should do more to promote a common understanding of key factors in assessing the quality and reliability of real-world data;
  • The FDA should work with other agencies and stakeholders to create a consistent system of recognition for reliable data and data sources;
  • The agency should clarify what it considers accepted techniques and standards for collection and continuous reporting of data;
  • The FDA’s draft guidance is too limited in scope—focusing heavily on registries—and the agency needs to be more expansive in its view of real-world data sources and uses.
  • Prospective and retrospective real-world data may be used to generate evidence to assess device safety and effectiveness, and the agency should include retrospective studies in the final guidance, if biases are sufficiently mitigated; and
  • The FDA should continue to work with industry and other stakeholders to ensure analytic methods utilized on large data sets minimize bias, while also maintaining data integrity.

“We have long held that leveraging technology and the data collected from such technology can hasten new treatments and cures,” wrote Horne. “We want to commend the FDA for its leadership in this space, and commit to working with you on ways to further embrace such use.”

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